# K231392: NaviNetics Reusable Stereotactic System (NN1000)

- Pathway: 510(k) (Traditional)
- Applicant: Navinetics, Inc.
- Decided: Jul 14, 2023 after 63 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K031999 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210700: NaviNetics D1 Stereotactic System, Navinetics, Inc. (2021) Summary page 4.

## Recalls of this device
- Feb 26, 2024 · Class II · Z-1478-2024: Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the locali

## Indications for use
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Source page: https://510kreport.com/device/K231392
Methodology: https://510kreport.com/methodology